Medix
Clinical Research Coordinator
We are seeking a
Clinical Research Coordinator.
The ideal candidate will have
at least 1 year of clinical research experience , hold
current IATA and GCP certifications , and be proficient in
phlebotomy . Responsibilities: Recruit, screen, and enroll participants for the clinical study. Obtain and document informed consent in compliance with
ICH-GCP
and institutional requirements. Conduct study visits and perform protocol-specific assessments, ensuring accurate and timely documentation in source according to
ALCOA-CC
principles. Perform phlebotomy, process, and ship blood and urine specimens in accordance with study protocols and
IATA shipping regulations . Accurately enter source data into electronic data capture (EDC) systems (e.g.,
Medidata RAVE ) and resolve data queries promptly. Conduct study-related procedures, including vital signs, ECGs, and other required assessments. Record, report, and follow up on adverse events (AEs) and serious adverse events (SAEs) per sponsor and regulatory guidance. Manage investigational product (IP) accountability, including dispensing, collection, temperature monitoring, and IRT system documentation. Coordinate and prepare for sponsor and CRO visits, including qualification, site initiation, monitoring, and close-out visits. Qualifications: Minimum
1 year of clinical research experience . Current
IATA
and
GCP
certifications required. Phlebotomy experience
required. Strong understanding of
ICH-GCP
guidelines and regulatory documentation standards. Excellent attention to detail, organization, and communication skills.
Clinical Research Coordinator.
The ideal candidate will have
at least 1 year of clinical research experience , hold
current IATA and GCP certifications , and be proficient in
phlebotomy . Responsibilities: Recruit, screen, and enroll participants for the clinical study. Obtain and document informed consent in compliance with
ICH-GCP
and institutional requirements. Conduct study visits and perform protocol-specific assessments, ensuring accurate and timely documentation in source according to
ALCOA-CC
principles. Perform phlebotomy, process, and ship blood and urine specimens in accordance with study protocols and
IATA shipping regulations . Accurately enter source data into electronic data capture (EDC) systems (e.g.,
Medidata RAVE ) and resolve data queries promptly. Conduct study-related procedures, including vital signs, ECGs, and other required assessments. Record, report, and follow up on adverse events (AEs) and serious adverse events (SAEs) per sponsor and regulatory guidance. Manage investigational product (IP) accountability, including dispensing, collection, temperature monitoring, and IRT system documentation. Coordinate and prepare for sponsor and CRO visits, including qualification, site initiation, monitoring, and close-out visits. Qualifications: Minimum
1 year of clinical research experience . Current
IATA
and
GCP
certifications required. Phlebotomy experience
required. Strong understanding of
ICH-GCP
guidelines and regulatory documentation standards. Excellent attention to detail, organization, and communication skills.